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Preimplantation Genetic Screening in Women Over 35 Year

This study has been completed.
Sponsor:
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00593671
First received: January 4, 2008
Last updated: January 14, 2008
Last verified: January 2008
History of Changes
  Purpose

In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to improve success rates after IVF, we test the hypothesis that patients with advanced maternal age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally normal embryos following PGS compared to patients who had an ET without PGS.

In a randomized controlled trial (RCT) in patients with AMA (≥ 35 years), the clinical IR per embryo transferred will be compared after ET on day 5 or 6 between the PGS group (embryo biopsy and analysis of chromosomes 13, 16, 18, 21, 22, X and Y) and the control group without PGS.


Condition Intervention
In Vitro Fertilization
 Procedure: Preimplantation genetic screening after embryo biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Preimplantation Genetic Screening for Aneuploidy in Embryos After in Vitro Fertilization in Women Over 35: a Prospective Controlled Randomized Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Clinical implantation rate per embryo transferred [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy rate per transfer [ Time Frame: end of study ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2002
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PGS group Procedure: Preimplantation genetic screening after embryo biopsy
Preimplantation genetic screening after embryo biopsy
No Intervention: control group

  Eligibility

Ages Eligible for Study:   35 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All couples with a medical indication for IVF and with a female age of at least 35 years are invited to participate in the study.

Exclusion Criteria:

  • Cycles were excluded from the study if ≤ 2 fertilized oocytes were available on day 1 after oocyte retrieval (OR), or if ≤ 2 ≥ 6c stage embryos were available on day 3 after OR.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593671

Locations
Belgium
Leuven University Fertility Center
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Study Director: Thomas M D'Hooghe, MD UZ Leuven
  More Information

No publications provided

Responsible Party: Thomas D'Hooghe, Leuven University Fertility Center
ClinicalTrials.gov Identifier: NCT00593671     History of Changes
Other Study ID Numbers: sdbroc0
Study First Received: January 4, 2008
Last Updated: January 14, 2008
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Katholieke Universiteit Leuven:
aneuploidies in 7 chromosomes increased with advanced maternal age

Additional relevant MeSH terms:
Aneuploidy
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013